Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2 | NCT01925118

Studies
Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2

NCT01925118

Sponsor

Seoul National University Hospital

Status

Terminated

Last Update Posted

Apr 26, 2016Estimated

Enrollment

9Actual

Phase

Phase 2

Conditions

Metastatic Malignant Melanoma and Renal Cell Carcinoma

Interventions

Irradiated donor lymphocyte infusion

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Ineffectiveness

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Aug 14, 2013

First Submission Date that Met QC Criteria

Aug 15, 2013

First Posted Date

Aug 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2016

Last Update Posted Date

Apr 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-dose IL-2	Experimental		Biological: Irradiated donor lymphocyte infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irradiated donor lymphocyte infusion	Biological		High-dose IL-2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
12-week modified immune-related response rate		12-week

Secondary Outcomes

Measure	Description	Time Frame
6-week modified immune-related response rate		6-week
Overall response rate based on RECIST v1.1		6/12-week
Progression-free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed malignant melanoma or renal cell carcinoma
At stage IV or relapse
At least one prior chemotherapy including targeted agents
At least one haploidential or partially matched-HLA donor
ECOG performance status 0-1
Age 18-75 years
Measurable lesion
Adequate bone marrow, liver, and renal functions

Exclusion Criteria:

Chemotherapy within 4 weeks
Stem cell transplantation
Active CNS metastasis
Hypersensitivity to IL-2

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma
D002292	Carcinoma, Renal Cell

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided